Achieve Life Sciences: 'Hold' On Expected CRL Cytisinicline And Q4 2026 NDA Resubmission

2026-05-13 15:17:34 ET

The last time I spoke about Achieve Life Sciences ( ACHV ) it was with a Seeking Alpha article entitled " Achieve Life Sciences: Maintaining 'Buy' On Upcoming PDUFA And Expansion Into Vaping Cessation ." With respect to this article, I mentioned that the company had its New Drug Application [NDA] of cytisinicline under review by the FDA for smoking cessation with a Prescription Drug User Fee Act [PDUFA] date of June 20, 2026. It also initiated a technology transfer to Adare [based in the United States] so that it could be responsible for manufacturing the cytisinicline supply for potential commercialization. The last time around I had a "Buy" rating on this stock, but I believe a downgrade is in order to a "Hold" rating....

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